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上海醫藥(02607.HK):利伐沙班片獲得批准生產
格隆匯 12-08 16:44

格隆匯12月8日丨上海醫藥(02607.HK)公吿,近日,公司下屬控股子公司常州製藥廠有限公司的利伐沙班片收到國家藥品監督管理局頒發的《藥品註冊證書》,該藥品獲得批准生產。

利伐沙班片是一種新型口服抗凝藥,主要通過抑制凝血因子Ⅹa因子活性,進而減少凝血酶(凝血因子Ⅱa)生成發揮抗凝作用,不影響已生成的凝血酶活性。臨牀上利伐沙班廣泛用於靜脈血栓栓塞性疾病的預防與治療,以及非瓣膜性房顫的卒中預防,具有起效迅速,療效可預測,顱內出血發生率低,無需常規凝血監測和常規調整劑量等優勢。利伐沙班片最早由拜耳公司研發,於2008年在歐盟上市。2019年12月,常州製藥廠就該藥品向國家藥監局提出註冊上市申請,並獲受理。

截至本公吿日,公司針對該藥品已投入研發費用約人民幣1,131.83萬元。截至本公吿日,中國境內該藥品的主要生產廠家有齊魯製藥有限公司、廣東東陽光藥業有限公司、吉林省博大製藥股份有限公司、浙江華海藥業股份有限公司、深圳信立泰藥業股份有限公司等。IQVIA數據庫顯示,2020年該藥品醫院採購金額為人民幣205,463萬元。

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